regulatory
confidence high
sentiment negative
materiality 0.75
PepGen withdraws PGN-EDODM1 Phase 1 timeline guidance pending FDA clinical hold
PepGen Inc.
- Withdrawing prior guidance to initiate a Phase 1 study of PGN-EDODM1 in DM1 in H1 2023.
- Awaiting official clinical hold letter from FDA; pausing additional regulatory filings to address the hold.
- CEO committed to working with FDA to lift the hold and start study as quickly as feasible.
- Company remains focused on advancing Phase 2 CONNECT1-EDO51 study in Duchenne muscular dystrophy, cleared by Health Canada in May 2023.